Quality Operations Manager
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Quality Operations Manager
- Location: Richmond, VA (On-site, not remote)
- Industry: Pharmaceutical
- Hours: M-F, 8am-5pm
- Employment Type: Direct hire
- Salary: Competitive compensation package, bonus potential and excellent benefits package
The Manager Quality Operations is responsible for planning, managing and tracking quality documentation, and having quality oversight of the operation of company s contract manufacturing organizations (CMOs). This role serves as the system owner for quality tools and technologies and develops processes to ensure that quality operations are in compliance with applicable cGXP requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, MST, etc.) to bring excellence in quality oversight and operational execution all products.
- Work closely and partner with the network of manufacturing, development and quality partners and has accountability for our interest in the quality and compliance aspect of these partnerships. Update management regarding status of deliverables and identify critical activities/risks.
- Responsible for the review and disposition of starting materials, packing materials, bulk and finished products for use or release as appropriate.
- Responsible for review of all associated quality operations documentation needed to support disposition including CAPA, Change Controls, Deviations and Batch Records.
- Responsible for calculating and compiling Key Performance Indicators and communicating any trends to management on a monthly basis.
- Ensure that appropriate compliance activities are maintained during operation to support cGMP compliance (calibration, validation, environmental monitoring).
- Support supplier/vendor qualification audit and inspection management.
- Support any customer/vendor compliance audit/inspections as required.
- Ensure company is prepared for all compliance inspections and support the on site inspections as required.
- Support system implementations of Quality owned IT software including eDMS, LMS, eQMS. Serve as the subject matter expert for implementation, training and ongoing system administration of these systems.
- Contribute to the creation and implementation of quality operations strategies for assigned projects and programs.
- Contribute to the review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.
- Manage vendors in support of quality operations.
- Manage all licensing requirements in compliance with FDA and state requirements.
- Provide operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections.
- Assist in tracking quality commitments and change control activities to ensure manufacturing changes are supported in accordance with regulatory requirements
- Understanding of GxP Regulations and Regulatory requirements required for Pharmaceutical productions, Active Pharmaceutical Ingredients.
- Experience working with API CMOs is highly desired
- Understanding of quality systems implementation including document management, CAPA, deviation, Change Control and training.
- Experience in implementing eDMS, eQMS and LMS applications. Experience working with Veeva quality systems is highly desired.
- Must be proficient in MS Sharepoint, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro.
- Demonstrated organizational skills, strong verbal and written communication skills, attention to detail
- Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred
- Ability to work in a cross-functional team environment with changing timelines and priorities required.
- Ability to travel to support supplier/vendor relationships and audit programs.
- Bachelor's degree in related Life Sciences discipline.
- 10+ years of relevant experience in GxP, Quality Operations positions in a Biotech or Pharmaceutical industry